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PrOtein and WEight Loss in teenageRs (POWER)

Primary Purpose

Pediatric Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Energy Restriction
Higher protein
Lower Protein
Sponsored by
Pennington Biomedical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pediatric Obesity focused on measuring Adolescent obesity, childhood obesity, anthropometry, body weights and measures

Eligibility Criteria

12 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Be male or female
  • Be between the ages of 12 and 17, inclusive
  • Be at or above the 85th BMI percentile (a number calculated from the participants height, weight, sex, and date of birth)
  • Be willing to fast for 12 hours prior to clinic study visits 2 and 4
  • Be willing to participate in the research study

Exclusion Criteria:

  • Health Conditions:
  • Has HIV or AIDS
  • Has uncontrolled CVD or arrhythmia
  • Has Type I or Type II diabetes.
  • Is unable or unwilling to complete the study procedures
  • Participant may not qualify for this study based on other exclusion criteria not listed. The study coordinator will go over this information in detail.

Medications:

  • Diuretics
  • Beta-blocker
  • Weight loss medications, diet pills
  • Anti-inflammatory drugs (corticosteroid/anabolic steroid/NSAID)
  • Antipsychotic medications
  • Other medications that may affect fluid balance or weight

Lifestyle:

• Plans to move out of the study area within the next 4 months, or plan to be out of the study area for more than 3 weeks during the course of the study.

Sites / Locations

  • Pennington Biomedical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Higher protein and energy restriction

Lower protein and energy restriction

Arm Description

Participants in this arm will consume 30% of energy as protein with 25% energy restriction.

Participants in this arm will consume 15% of energy as protein with 25% energy restriction.

Outcomes

Primary Outcome Measures

BMI Z-Score

Secondary Outcome Measures

Subjective Ratings of Appetite
Hexosamine Biosynthetic Pathway
glutamine fructose-6-phosphate amidotransferase (GFAT) and glycosylation measured as O-linked N-acetylglucosamine (GlcNAc) transferase (OGT) measurement

Full Information

First Posted
March 3, 2014
Last Updated
January 7, 2016
Sponsor
Pennington Biomedical Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT02079831
Brief Title
PrOtein and WEight Loss in teenageRs
Acronym
POWER
Official Title
Effects of Varied Macronutrient Composition on Weight Loss in Obese Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pennington Biomedical Research Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the proposed study is to provide important data on weight loss efficacy in overweight and obese adolescents on an isocaloric higher protein diet vs a lower protein diet utilizing the U.S. Department of Agriculture (USDA) MyPlate nutrition guide. The investigators hypothesize that the higher protein diet will result in greater weight loss due to increased satiety and better dietary adherence.
Detailed Description
Aim 1 is to test the efficacy of a personalized higher protein weight loss intervention compared to a lower protein intervention which use the USDA MyPlate nutrition guide. It is hypothesized that participants randomly assigned to the higher protein dietary treatment will lose more weight based on BMI-Z score over 12 weeks compared to participants in the lower dietary protein treatment. Aim 2 is to test if changes in subjective ratings of appetite differ by dietary treatment (i.e. protein intake). It is hypothesized that participants in the higher protein intervention will report a decrease in hunger and an increase in fullness compared to participants in the lower protein intervention. Aim 3 is to test if change in the hexosamine biosynthetic pathway (HBP) measured at the rate limiting step of glutamine fructose-6-phosphate amidotransferase (GFAT) and glycosylation measured as O-linked N-acetylglucosamine (GlcNAc) transferase (OGT) differ by dietary treatment. It is hypothesized that participants randomly assigned to the higher protein dietary treatment will have decreased change from baseline levels of GFAT and glycosylation (OGT) due to decreased carbohydrate intake compared to the lower protein treatment. Exploratory Aims: As exploratory aims, the investigators will test if the higher protein or lower protein dietary treatments differentially alter glucose, insulin, cholesterol, and triglycerides (markers of the metabolic syndrome).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity
Keywords
Adolescent obesity, childhood obesity, anthropometry, body weights and measures

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Higher protein and energy restriction
Arm Type
Experimental
Arm Description
Participants in this arm will consume 30% of energy as protein with 25% energy restriction.
Arm Title
Lower protein and energy restriction
Arm Type
Experimental
Arm Description
Participants in this arm will consume 15% of energy as protein with 25% energy restriction.
Intervention Type
Behavioral
Intervention Name(s)
Energy Restriction
Intervention Description
Participants will receive an intervention specifically designed for adolescents and their group assignment that relies on nutrition education, nutritional counseling, social cognitive therapy, behavioral strategies, self-monitoring, portion size reduction, and increased physical activity. Participants will get an individualized dietary meal plan. Dietary counseling will be based on the MyPlate guidelines with extra attention and focus on appropriate protein food choice. Also in accordance to the MyPlate guidelines, all participants will be instructed to increase physical activity to 60 minutes a day as aerobic physical activity.
Intervention Type
Behavioral
Intervention Name(s)
Higher protein
Intervention Description
The higher protein group will be instructed to consume 30% of energy as protein, with 25% and 45% of energy from fat and carbohydrate, respectively.
Intervention Type
Behavioral
Intervention Name(s)
Lower Protein
Intervention Description
The lower protein group will be instructed to consume 15% of energy as protein, with 25% and 60% of energy from fat and carbohydrate, respectively.
Primary Outcome Measure Information:
Title
BMI Z-Score
Time Frame
up to Week 12
Secondary Outcome Measure Information:
Title
Subjective Ratings of Appetite
Time Frame
Baseline and Week 12
Title
Hexosamine Biosynthetic Pathway
Description
glutamine fructose-6-phosphate amidotransferase (GFAT) and glycosylation measured as O-linked N-acetylglucosamine (GlcNAc) transferase (OGT) measurement
Time Frame
Baseline and Week 12
Other Pre-specified Outcome Measures:
Title
Glucose
Time Frame
Baseline and Week 12
Title
Insulin
Time Frame
Baseline and Week 12
Title
Cholesterol
Time Frame
Baseline and Week 12
Title
Triglycerides
Time Frame
Baseline and Week 12
Title
Blood Pressure
Time Frame
Baseline and Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Be male or female Be between the ages of 12 and 17, inclusive Be at or above the 85th BMI percentile (a number calculated from the participants height, weight, sex, and date of birth) Be willing to fast for 12 hours prior to clinic study visits 2 and 4 Be willing to participate in the research study Exclusion Criteria: Health Conditions: Has HIV or AIDS Has uncontrolled CVD or arrhythmia Has Type I or Type II diabetes. Is unable or unwilling to complete the study procedures Participant may not qualify for this study based on other exclusion criteria not listed. The study coordinator will go over this information in detail. Medications: Diuretics Beta-blocker Weight loss medications, diet pills Anti-inflammatory drugs (corticosteroid/anabolic steroid/NSAID) Antipsychotic medications Other medications that may affect fluid balance or weight Lifestyle: • Plans to move out of the study area within the next 4 months, or plan to be out of the study area for more than 3 weeks during the course of the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John W Apolzan, PhD
Organizational Affiliation
Pennington Biomedical
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States

12. IPD Sharing Statement

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PrOtein and WEight Loss in teenageRs

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